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BACKGROUND: A study titled 'Integration of AYUSH (Ayurveda) with National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)' implemented in India in three districts of three states, namely Bhilwara (Rajasthan), Gaya (Bihar), and Surendranagar (Gujarat) since 2015 for the management of various non-communicable diseases (NCDs) through integrated approach. OBJECTIVE(S): To evaluate the effect of Ayurveda medication, lifestyle modification, and Yoga in integration with standard care for the management of essential hypertension. MATERIAL AND METHODS: A retrospective analysis of the demographic and clinical records available from NPCDCS-AYUSH Integration Project was done. The data of participants with Essential Hypertension (EHTN), aged between 30 and 60 years, who had completed six months integrated management as per the treatment protocol of the NPCDCS-AYUSH Integration project between July 2018 and March 2019 were taken and distributed in two groups based on their intervention. Those advised for lifestyle modification and Yoga in addition to standard care with any of the five medicines/combinations i.e. Amlodipine or Atenolol or Amlodipine + Atenolol or Losartan or Telmisartan were assigned Group I and those who were given Ayurveda medication, lifestyle modification and Yoga in addition to standard care were assigned to Group II. The change in blood pressure was analysed and dose reduction/discontinuation of conventional medications was also observed. RESULTS: Data of 1938 participants who had completed treatment under the NPCDCS program was analysed. At the 6th month, systolic and diastolic blood pressure was significantly reduced (P < 0.01) in all categories of Group I and Group II from baseline. Further, the dose of conventional medicine was reduced in 33.1% of participants of Group I and in 30.4% participants of Group II when compared to 0 day while conventional medicines were discontinued in 15.1% of Group I and 36.7% of Group II participants. CONCLUSION: Ayurveda medication along with lifestyle management and Yoga effectively controls systolic and diastolic blood pressure and further helps in reducing/discontinuation of dose of conventional medicines in EHTN participants.
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Background: The burden of iron-deficiency anemia (IDA) remains persistently high in India due to the poor tolerability of oral iron supplementation. Therefore, more focus is required to explore traditional medicine for safe and effective options for managing IDA. Aim: To assess the clinical safety and efficacy of Dhatri Lauha in patients with IDA. Materials and methods: An open-label, prospective, single-arm, multi-center trial was conducted at 12 centers with a sample size of 40 participants per study site. Patients with IDA aged 18-60 years with hemoglobin levels in the range of 6-10gm/dl, mean corpuscular volume (MCV) <80 fl, mean corpuscular hemoglobin concentration (MCHC) <34 µg/dl, serum ferritin <30 µg/dl and serum iron <50 µg/dl were included in the study. Dhatri Lauha 500 mg capsule was administered twice daily with lukewarm water after meals for 45 days. The primary outcome measure was the change in hemoglobin (Hb%) level from baseline to day 45. Secondary outcome measures included the change in MCV, MCHC, serum iron and ferritin levels, incidence of adverse events, and change in safety parameters (liver and kidney function tests). The mean (statistical) change in outcome measures from baseline to day 45 was compared using a paired sample t-test. Results: Out of 458 participants enrolled in the study, 400 contributed to the final analysis. A significant difference was observed in the outcome parameters such as Hb%, MCV, MCHC, serum ferritin, and serum iron levels (P < 0.001) after 45 days of treatment. Mean Hb% changed from 8.46 ± 1.14 g/dl at baseline to 9.18 ± 1.61 g/dl on day 45 (P < 0.001). LFT and KFT were within the normal limits after the study period. No participant withdrew from the study due to adverse events. Conclusions: Dhatri Lauha is a safe intervention and can be expected to improve hemoglobin levels, red blood cell parameters, and iron stores in patients with IDA. Future RCTs with a larger sample size, standard care as control and a longer follow-up may produce more accurate and reliable results.
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BACKGROUND: Type 2 diabetes is a lifestyle-related disorder that affects around 422 million individuals in India. Integration of AYUSH (Ayurveda) with the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) was conceived on pilot basis at Gaya, Bihar, to provide integrative treatment for non-communicable disease patients and to manage the burden of non-communicable diseases in India. OBJECTIVES: The objective of this study was to analyze the effect of Ayurveda intervention, lifestyle modification and Yoga in the management of type 2 diabetes under NPCDCS-AYUSH integration project. MATERIALS AND METHODS: A multi-centric, open-labeled, prospective, comparative clinical study was conducted at 17 community health centers and 1 district hospital. Population over 30 years of age was screened and prediabetic or type 2 diabetic individuals were enrolled in two cohorts, i.e., pre-diabetic (Cohort A) and type 2 diabetic (Cohort B). Each cohort was further divided into two groups: Group A1 was advised for lifestyle modification and Yoga and group A2 was given Ayurveda medication in addition to lifestyle modification and Yoga. Similarly, group B1 was advised for lifestyle modification and Yoga along with allopathic medication and group B2 was given Ayurveda medication, i.e., Mamajjaka, Amalaki and Guduchi powder in addition to lifestyle modification and Yoga along with allopathic medication. Treatment was given for 6 months. Data were analyzed through paired t-test. RESULTS: A significant reduction was observed in fasting blood sugar level in groups A2 and B2 (P = 0.001) and also in the postprandial blood sugar level in Groups A2 and B2 (P = 0.001). Further, improvement in subjective symptoms such as polyuria, polydipsia, polyphagia, blurred vision and weakness was found in all the groups, while non-healing ulcer does not show any improvement. CONCLUSION: The study reveals that Ayurveda intervention, i.e., Mamajjaka Churna (1 g), Amalaki Churna (3 g) and Guduchi Churna (3 g) two times a day effectively controls blood sugar level in pre-diabetic and type 2 diabetic patients and improves the disease management with lifestyle modification and Yogasana as well as with allopathic treatment.
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BACKGROUND: Yoga is considered to be one of the most important, effective, and valuable tools available for man to overcome various physical and psychological problems. Stress contributes significantly to the pathogenesis of periodontal diseases; hence, it becomes important to reduce the level of stress for prevention and management of diseases. AIMS AND OBJECTIVES: The present study was aimed: (1) To understand and analyze the possibilities of employing yogic practices in the treatment of periodontal disease along with conventional dental therapy, (2) to understand the effect of stress on periodontal treatment outcome, (3) to evaluate the efficacy of yoga in the management of periodontal disease with reference to stress. MATERIALS AND METHODS: An outpatient department-based parallel group randomized study was performed with standard treatment for periodontal disease yoga therapy as Group II and only standard treatment as Group I. Periodontal health status was recorded using indices of modified plaque index (PI), bleeding on probing (BOP), probing depth, and clinical attachment loss (CAL). The Cohen's perceived stress questionnaire was also used to determine stress severity. The yogic intervention consists of lectures and practical sessions on asanas, pranayama, kriyas, and meditation. RESULTS: Repeated measure analysis of variance revealed a significant difference (P < 0.001) in all the outcome variables with respect to time in both groups. It was observed that mean PI score reduced by 1.35 in Group II as compared to 0.54 in Group I, mean probing pocket depth reduced by 1.60 in Group II as compared to only 0.68 in Group I, and mean CAL score reduced by 1.60 in Group II as compared to 0.68 in Group I. Similarly, Cohen's perceived stress scale score also reduced by 18.76 points in Group II as compared to only 2.58 points in Group I, BOP also shows better improvement in Group II with a reduction of 0.68 as compared to reduction of only 0.08 in Group I. The results obtained ascertained the role of yoga in stress reduction in periodontal disease. CONCLUSION: Although yoga does not play a direct role in improving periodontal disease, it accelerates the treatment outcomes by combating the stress which is a major factor affecting the treatment of periodontal disease.
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Statistics is an integral part of Clinical Trials. Elements of statistics span Clinical Trial design, data monitoring, analyses and reporting. A solid understanding of statistical concepts by clinicians improves the comprehension and the resulting quality of Clinical Trials. In biomedical research it has been seen that researcher frequently use t-test and ANOVA to compare means between the groups of interest irrespective of the nature of the data. In Clinical Trials we record the data on the patients more than two times. In such a situation using the standard ANOVA procedures is not appropriate as it does not consider dependencies between observations within subjects in the analysis. To deal with such types of study data Repeated Measure ANOVA should be used. In this article the application of One-way Repeated Measure ANOVA has been demonstrated by using the software SPSS (Statistical Package for Social Sciences) Version 15.0 on the data collected at four time points 0 day, 15(th) day, 30(th) day, and 45(th) day of multicentre clinical trial conducted on Pandu Roga (~Iron Deficiency Anemia) with an Ayurvedic formulation Dhatrilauha.